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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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34 records meeting your search criteria returned- Product Code: QKP Product Problem: Defective Component Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
HUMASIS CO., LTD. DIATRUSTTM COVID-19 AG HOME TEST 05/08/2023
IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 11/07/2022
ANDON MEDICAL CO.,LTD IHEALTH 10/24/2022
ANDON MEDICAL CO.,LTD IHEALTH 10/24/2022
ANDON MEDICAL CO.,LTD IHEALTH 10/24/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 09/21/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 09/21/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 09/21/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 09/21/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 09/21/2022
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